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Inductive Camrelizumab and Apatinib for Patients With Locally Advanced and Resectable Oral Squamous Cell Carcinoma

NCT ID: NCT04393506

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-23

Study Completion Date

2023-11-10

Brief Summary

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In patients with locally advanced oral squamous cell carcinoma (OSCC), due to the large tumor burden and neck lymph node metastasis, comprehensive treatment is recommended, including surgery, radiotherapy, chemotherapy and others. Pre-operative inductive therapy can reduce tumor volume, increase organ retention rate, and reduce distant metastasis rate. Vascular endothelial growth factor (VEGF) receptor in head and neck squamous cell carcinoma is over-expressed and associated with disease invasion and poor prognosis. The use of targeted therapy against VEGF can not only inhibit tumor neovascularization, but also make the effectiveness of chemotherapeutic agents. VEGF and VEGFR are closely related to immune escape. Tumor growth requires new blood vessels to supply nutrients and oxygen, and VEGF can stimulate neovascularization. However, tumor neovascularization is often abnormal and distorted, which prevents immune active substances from reaching the tumor site. After tumor hypoxia, high expression of VEGF will induce tumor cells to express programmed cell death protein-1 (PD-1), which further leads to immune escape. Targeted drugs against angiogenesis can relieve immunosuppression to a certain extent, and theoretically have a synergistic effect with anti-PD-1 immunotherapy. The innovation of this study is the combination of immune checkpoint inhibitor, Camrelizumab, and targeted drug against VEGFR, Apatinib, as an inductive therapy to treat the patients with locally advanced OSCC, followed with radical surgery and post-operative radiotherapy/chemoradiotherapy, the major pathologic response and safety will be evaluated as the primary surrogate endpoints, the 2-year survival rate and local recurrence rate will be the second endpoints.

Detailed Description

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Conditions

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Oral Cancer VEGFR2 Inhibitor Programmed Cell Death 1 Inhibitor Inductive Therapy

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Inductive therapy

Inductive therapy with Camrelizumab and Apatinib, followed by radical surgery and post-operative radiotherapy/chemoradiotherapy.

Group Type OTHER

Camrelizumab

Intervention Type DRUG

Inductive therapy with Camrelizumab of 200mg, iv, qd, on day 1, 15, 29.

Apatinib

Intervention Type DRUG

Inductive therapy with Apatinib of 250mg, po, qd, initiating on day 1, ending on the fifth day before surgery.

Radical surgery

Intervention Type PROCEDURE

Radical surgery will be performed on the 42th-45th after initiation of inductive therapy

Post-operative radiotherapy/chemoradiotherapy

Intervention Type RADIATION

Post-operative radiotherapy/chemoradiotherapy will be performed within 1.5 months after radical surgery, depending on the post-operative pathologic diagnosis.

Interventions

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Camrelizumab

Inductive therapy with Camrelizumab of 200mg, iv, qd, on day 1, 15, 29.

Intervention Type DRUG

Apatinib

Inductive therapy with Apatinib of 250mg, po, qd, initiating on day 1, ending on the fifth day before surgery.

Intervention Type DRUG

Radical surgery

Radical surgery will be performed on the 42th-45th after initiation of inductive therapy

Intervention Type PROCEDURE

Post-operative radiotherapy/chemoradiotherapy

Post-operative radiotherapy/chemoradiotherapy will be performed within 1.5 months after radical surgery, depending on the post-operative pathologic diagnosis.

Intervention Type RADIATION

Other Intervention Names

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Humanized anti-PD-1 inhibitor VEGFR2 inhibitor

Eligibility Criteria

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Inclusion Criteria

* Eastern cooperative oncology group performance status (ECOG PS) score: 0-2 points
* Pathological diagnosis of oral squamous cell carcinoma (including tongue, gums, cheeks, mouth floor, hard palate, posterior molar region)
* Clinical stage of III/IVA (AJCC 2018)
* Blood routine: white blood cells\> 3,000/mm3, hemoglobin\> 8g/L, platelets\> 80,000/mm3
* Liver function: Alanine Transaminase/Aspartate Transaminase \<2.5 times the upper limit of normal, bilirubin \<1.5 times the upper limit of normal
* Renal function: serum creatinine \<1.5 times the upper limit of normal
* Sign the informed consent

Exclusion Criteria

* There are still unresolved toxic reactions above CTCAE level 2 caused by previous anti-cancer treatment
* Obvious cardiovascular abnormalities \[such as myocardial infarction, superior vena cava syndrome, heart disease of grade 2 or higher diagnosed according to the classification criteria of the New York Heart Association (NYHA) 3 months before enrollment\]
* Active severe clinical infection (\> CTCAE 5.0 version 2 infection)
* Difficult to control hypertension (systolic blood pressure\> 150 mmHg and / or diastolic blood pressure\> 90 mmHg) or cardiovascular disease with clinical significance (such as activity)-such as cerebrovascular accident (≤ 6 months before randomization), myocardial infarction (≤6 months before randomization), unstable angina, New York Cardiology Society (NYHA Appendix 5) congestive heart failure grade II or above, or severe arrhythmia that cannot be controlled with drugs or has potential impact on experimental treatment
* Women during pregnancy or lactation
* Participated in other clinical studies within 30 days before enrollment
* Other circumstances that the investigator thinks are not suitable for participating in the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Lai-ping Zhong

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lai-ping Zhong, PHD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Locations

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Shanghai Ninth People's Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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Ju WT, Xia RH, Zhu DW, Dou SJ, Zhu GP, Dong MJ, Wang LZ, Sun Q, Zhao TC, Zhou ZH, Liang SY, Huang YY, Tang Y, Wu SC, Xia J, Chen SQ, Bai YZ, Li J, Zhu Q, Zhong LP. A pilot study of neoadjuvant combination of anti-PD-1 camrelizumab and VEGFR2 inhibitor apatinib for locally advanced resectable oral squamous cell carcinoma. Nat Commun. 2022 Sep 14;13(1):5378. doi: 10.1038/s41467-022-33080-8.

Reference Type DERIVED
PMID: 36104359 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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Icemelting trial

Identifier Type: -

Identifier Source: org_study_id